GESTONE

Posology Dysfunctional uterine bleeding 5 – 10 mg daily for 5 - 10 days until 2 days before anticipated onset of menstruation. Maintenance of pregnancy Twice weekly or more frequent (maximum: daily) injections of 25-100 mg from approximately day 15, or day of transfer of embryo or gametes usually until 8 - 16 weeks of pregnancy when secretion of progesterone from the placenta should be established.

Daily dosage can be increased to 200 mg at the discretion of the physician. Special Populations The indications for Gestone 50mg/ml solution for injection are restricted to women of child-bearing age. Elderly Dosage recommendations for the elderly are not appropriate.

Paediatric population Dosage recommendations for children are not appropriate. Method of administration For intramuscular use. Gestone 50 mg/ml solution for injection is given by intramuscular injection. 8cm) needle. This site has ample fat cells where a depot of progesterone can be formed for slow release.

Post-Marketing experience The information given below is based on post-marketing experience from the administration of progesterone. Adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data).

System organ class Frequency Not known (cannot be estimated from the available data) Gastrointestinal disorders Nausea General disorders and administration site conditions Injection site reaction, Oedema Hepatobiliary disorders Pyrexia, Cholestatic jaundice Immune System Disorders Allergic reaction Investigations Weight gain Metabolism and nutrition disorders Catabolism increased Psychiatric disorders Insomnia, Depression mental, Somnolence Reproductive system and breast disorders Amenorrhoea, Breakthrough bleeding, Menstrual flow altered, Erosion and ectropion of the cervix, Cervical discharge, Breast fibrocystic changes Skin and subcutaneous tissue disorders Acne, Alopecia, Chloasma, Hirsutism, Rash Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store).

g. hypertension, cardiac disease, renal disease, epilepsy), with a history of mental depression, diabetes, mild to moderate hepatic dysfunction, acute intermittent porphyria, migraine or photosensitivity. If unexplained, sudden or gradual, partial or complete loss of vision, proptosis or diplopia, papilloedema, retinal vascular lesions or migraine occur during therapy, the drug should be discontinued and appropriate diagnostic and therapeutic measures instituted.

Excipient with known effect:

Gestone 50 mg/ml Solution for Injection contains benzyl alcohol which may cause allergic reactions. Gestone 50 mg/ml Solution for Injection contains benzyl alcohol, large amounts of benzyl alcohol can build up in the body causing metabolic acidosis.

Therefore, Gestone 50 mg/ml Solution for Injection must be used with caution in patients who have liver or kidney disease and those who are breast-feeding (also refer to section

1. Hypersensitivity to progestins, undiagnosed vaginal bleeding, missed or incomplete abortion, mammary or genital tract carcinoma, thrombophlebitis, cerebral haemorrhage, marked hepatic dysfunction. Contraindicated as a diagnostic test for pregnancy.